Background and aims: SpyGlass single operator cholangioscopy (SOC) system is generally considered safe but adds additional risks to those associated with standard endoscopic retrograde cholangiopancreatography. Methods: We evaluated adverse events (AEs) with the SpyGlass System reported in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2016 & August 2023. Results: A total of 2331 device problems (SpyGlass DS:1301, SpyGlass DS II:1010) were reported. An optical problem was the most reported issue with 83 for the SpyGlass DS and 457 for the SpyGlass DS II. Patient related events were found in 62 (3.5%) of 1743 reports: 33 with SpyGlass DS, and 29 with SpyGlass DSII. The most common AEs were bleeding/hemorrhage followed by perforation, infection, fever, or sepsis and pancreatitis. Conclusions: Our findings add to the existing literature and provides a fuller picture of potential problems associated with SpyGlass™ SOC.
Adverse Events of the Single Operator Cholangioscopy System: A MAUDE Database Analysis
Facciorusso, Antonio;
2024-01-01
Abstract
Background and aims: SpyGlass single operator cholangioscopy (SOC) system is generally considered safe but adds additional risks to those associated with standard endoscopic retrograde cholangiopancreatography. Methods: We evaluated adverse events (AEs) with the SpyGlass System reported in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2016 & August 2023. Results: A total of 2331 device problems (SpyGlass DS:1301, SpyGlass DS II:1010) were reported. An optical problem was the most reported issue with 83 for the SpyGlass DS and 457 for the SpyGlass DS II. Patient related events were found in 62 (3.5%) of 1743 reports: 33 with SpyGlass DS, and 29 with SpyGlass DSII. The most common AEs were bleeding/hemorrhage followed by perforation, infection, fever, or sepsis and pancreatitis. Conclusions: Our findings add to the existing literature and provides a fuller picture of potential problems associated with SpyGlass™ SOC.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
